Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Anemia Clinical Trial

Official title:

Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906295
• Other study ID #: H-D-2009-024
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: June 3, 2011
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Patients undergoing replacement of hip arthroplasty

• Be legally competent

• Read and understand Danish

Exclusion Criteria:

• Present malignant disease

• Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Arthroplasty
• Hip
• Replacement

Intervention

Other:
• Allowed drop in hemoglobin to 4.5-5.5 mmol/L
Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)
• Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L
Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen	Østerbro

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go-test (TUG)in seconds.	Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.	30 days	No
Secondary	The postoperative day patients can walk ten meters		30 days	No
Secondary	Length of stay at hospital		30 days	No
Secondary	The day the patient is able to perform Timed Up and Go-test		30 days	No

External Links

•   Official hospital homepage